Senior Scientist II, Quality Control & Analytical

  • Location

    Germany
  • Salary

    Negotiable
  • Job Type

    Permanent
  • Functions

    Technical Operations

Senior Scientist II, Quality Control

Overseeing the whole Analytical lifecycle

Location: Berlin

Summary

Clinical stage Biotech creating a new generation of therapeutics that improve patient outcomes and, in the process, build shareholder value.

They are developing a deep pipeline of innovative therapeutics for diseases with a genetic basis. The depth and versatility of their technology gives an opportunity to address a wide range of conditions in virtually any therapeutic area. Their wholly owned pipeline is currently focused in three therapeutic areas of high unmet need: hematology, cardiovascular, and rare diseases.

Role Purpose

The company is growing its CMC team to support their maturing pipeline and approach to GMP Compliance. A key piece to this is strengthening their Analytics and Quality Control methodologies.

As Senior Scientist II, Quality Control, you will be joining the growing CMC GMP Quality Team, while being an integral part of the broader Analytical community in CMC.

You will guide and oversee the development of new analytical methods across all aspects of the lifecycle, including method transfer to CROs and CMOs, validation and ongoing monitoring.

You will provide Quality level oversight to analytical activities performed at CMOs related to GMP manufacturing and help resolve any issues related to analytics. Additionally, you will serve as a GMP subject matter expert for all topics related to analytics, providing guidance to colleagues in product and impurity characterization, method development and transfer.

Finally, you will support development of documentation enabling successful Regulatory submissions to help move the pipeline closer to market.

Key Responsibilities

  • Share expertise in analytics and GMP QC practices for raw materials and siRNA compounds.
  • Oversee delivery of analytical methods to support drug development and commercialisation, using state-of-the-art approaches.
  • Review and approve Method Development, Transfer and Validation Documentation.
  • Develop Stability Protocols for therapeutic products, based on industry guidance.
  • Review and approve OOS/OOTs received from CMOs.
  • Share analytical expertise to Deviation investigations.
  • Oversee the development of analytical control strategies.
  • Help guide the establishment of specifications. Execute project-related activities on time and within budget.
  • Help produce and archive CMC regulatory documentation for the analytical sections of INDs/IMPDs, briefing documents, and eventually for the registration file. Give support during scientific advice meetings with regulatory authorities.
  • Participate in Audits where QC is concerned.

Experience and Qualifications

  • Advanced Degree (PhD preferred) in Chemistry/ Biochemistry or similar, with experience in chromatographic and spectrometric methods for characterising molecules (oligonucleotides / peptides / biologics)
  • Several years’ experience working hands-on in GMP Quality Control, supporting testing of clinical or commercial therapeutic products.
  • Broad hands-on experience in analytical method lifecycle (HPLC MS and UV) including method development, qualification transfer and monitoring.
  • Experience setting up and maintaining stability studies for therapeutic products.
  • Experience working with CROs/CMOs would be advantageous.
  • Excellent written and verbal communication skills in English, German would be advantageous.
  • Proven ability to effectively prioritise workload and strong organisational skills.
  • Motivated to undertake a diverse role and add value to this growing organisation.

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